Diabetes Mellitus, Type 2DIAPOWNCT04332302
Power Strength Training in Type 2 Diabetic Mellitus Older Adults
A study testing Power resistance training in people with Diabetes Mellitus, Type 2 and Frailty, run by Technical University of Madrid at 1 site in Spain.
Trial summary
Diabetes is a disease with a high impact in the population older than 65 years old. Some indications suggest that diabetes in the old age aggravate the negative effects of ageing, as the loss of muscle mass and strength, bringing the patients to a situation of vulnerability and elevated risk of disability and death… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Frailty
- What is being tested?
- Power resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2020to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Sign an informed consent.
- Older than 65 years old with Type 2 Diabetes Mellitus diagnosed in a minimum of 2 previous years.
- Being diagnosed frail, pre-frail or no frail.
Who cannot join
- Barthel's index lower than 60 points.
- Incapacity to complete the SPPB fitness test.
- Score lower than 20 points in the Mini Mental State Examination.
- Cardiovascular event in the previous 6 months following the New York Heart Association (NYHA) classification.
- Patients clinically unstable by the investigator's judgement.
- Terminal disease (life expectancy lower than 6 months).
- Participation in another study that could interfere in the results of the current research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Exercise Program on Physical Functionality and Frailty in Type 2 Diabetic Older Adults. Role of Circulating Concentration of PDEF and Differential Genes
Diabetes is a disease with a high impact in the population older than 65 years old. Some indications suggest that diabetes in the old age aggravate the negative effects of ageing, as the loss of muscle mass and strength, bringing the patients to a situation of vulnerability and elevated risk of disability and death known as "frailty syndrome". Recently, scientists have observed that if older population train with musculation machines emphasising the muscular power, it is possible to have an impact on a disminution of frailty and restoring the physical functionality. This project deeps in the physiological and molecular mechanisms that underlie to improvements in the frail diabetic patients.
Read the detailed description
It is hypothesised that:
- High intensity training (strength-power) prescribed properly in an individualised form and supervised could influence significantly on the phenotypic response in the DM type 2: decreasing the level of clinical severity, disability and frailty, improving quality of life and glycaemic control, functional capacity and body composition (especially the muscle mass) of the diabetic patients (type 2) older than 65 years old.
- Part of the training adaptations in diabetic patients (type 2) older than 65 years old could due to physiological conditions as the systemic level of biomarkers as PDEF in these patients.
- Part of the training adaptations in diabetic patients (type 2) could be influenced by the characterisation of associated genes to the different types of DM type 2 recently characterised.
The principal aims are:
- To evaluate the effectiveness of a novel intervention based on strength-power exercise in individuals older than 65 years old with DM type 2 and frailty in term of: level of clinical severity, disability, glycaemic control, quality of life, functional capacity, state of frailty and body composition.
- To establish whether PDEF serves as diagnostic and prediction biomarker to training response, providing an objective and accessible method that would stratify the response to the intervention helping with the patients screening.
- To determine the role of characterised genetic variants in the different subgroups of DM type 2 in the level of response to the training stimuli.
Study design Longitudinal intervention stratified study, controlled and single-blinded, with a group of intervention and control group.
Based on data from a previous study recently published by the collaborators of this project. The sample size was calculated to get statistically significant differences in the physical functionality using ANCOVA and performing a bilateral contrast with alpha=0.05 of the effect of the group (with any of the independent variables), and it is needed 30 subjects by group (total n=60) to get a statistical power of 80%, with a partial eta ≥ 0.101 (value that corresponds with the size of the moderate effect).
Exercise program The intervention period will have a duration of 12 weeks, in which the training group will perform 2 sessions per week (24 sessions in total), while the control group will not perform any type of intervention, following their normal lifes and the habitual medical cares. The experimental group will perform a program focused on the muscle power training, in which there will be included exercise of upper limbs (chest press) and lower limbs (leg press). The exercises will be performed in muscle-building machines available in the reference institutions of the collaborators. It is important to point out that the intensity in the exercises will be individualised for any patient through a test of determination of muscle power validated previously by the consortium of researchers and the subjects will perform the exercises at this intensity at which the subjects will develop their maximal muscle performance, with the performance of 3-4 bouts of 8 repetitions in each exercise. After the third week of intervention, it will be put the attention to the speed of execution. The duration of each session has been estimated in 20-30 minutes.
Finally, the subjects in the control group will serve to compare the interventions with exercise and the clinical conventional treatment, as well as to determine whether the training program is able to restore the functional capacity in a similar way in diabetic patients without frailty.
- Conditions
- Diabetes Mellitus, Type 2, Frailty
- Being tested
- Power resistance training
- Keywords
- Resistance Training, Quality of Life, Molecular Genetics, Skeletal Muscle
- Medical subject headings
- Diabetes Mellitus, Type 2, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power resistance trainingOther
Participants will take part in an intervention of 12 weeks duration in which they will train with musculation machines.
| Study group | Role | What they receive |
|---|---|---|
| Power training group | Experimental | Participants will be enrolled in a resistance training program. Receives: Other: Power resistance training |
| Control group | No intervention | Participants will be doing their normal life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks
Percentage
Measured: 0 and 12 weeks.
Change from Baseline Homeostasis Model Assessment - Beta cells (HOMA2-B) at 12 weeks
Percentage
Measured: 0 and 12 weeks.
Change from Baseline Homeostasis Model Assessment - Insuline Resistance (HOMA2-IR) at 12 weeks
Percentage
Measured: 0 and 12 weeks.
Change from Baseline Fried frailty score at 6 and 12 weeks
Level of frailty assessed by Fried Criteria. Intermediate or prefrail: 1 or 2 criteria present. Positive for frailty phenotype: ≥3 criteria present.
Measured: 0, 6 and 12 weeks.
Change from Baseline Functional capacity at 6 and 12 weeks
Level of functional capacity assessed by the test SPPB. Scores 0-3: Very low physical function; Scores 4-6: Low physical function; Scores 7-9: Moderate physical function; Scores 10-12: High physical function
Measured: 0, 6 and 12 weeks.
Change from Baseline Disability at 6 and 12 weeks
Level of disability assessed by the Barthel test. A participant scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.
Measured: 0, 6 and 12 weeks.
Functional mobility at 6 and 12 weeks
Level of functional mobility assessed by the Lawton test. A scale from 0 to 8, expressing higher scores better levels of independence.
Measured: 0, 6 and 12 weeks.
Change from Baseline Muscular power at 6 and 12 weeks
Watts.
Measured: 0, 6 and 12 weeks.
Change from Baseline Levels of strength at 6 and 12 weeks
Load (kg).
Measured: 0, 6 and 12 weeks.
Change from Baseline Bone Mineral Density at 12 weeks
g/cm3
Measured: 0 and 12 weeks.
Change from Baseline Pigment Epitelium Derived Factor (PEDF) at 12 weeks
Circulating level of PDEF assessed by Western Blot.
Measured: 0 and 12 weeks.
Genotyping of TCF7L2 (rs7903146)
Assessed by Real-time PCR.
Measured: 0 week.
Genotyping of TM6SF2 (rs10401969)
Assessed by Real-time PCR.
Measured: 0 week.
Genotyping of HLA (rs2854275)
Assessed by Real-time PCR.
Measured: 0 week.
Secondary outcomes (10)
Change from Baseline Body Mass Index at 6 and 12 weeks
Kg by square meters.
Measured: 0, 6 and 12 weeks.
Change from Baseline Waist circumference at 6 and 12 weeks
Meters.
Measured: 0, 6 and 12 weeks.
Change from Baseline Blood pressure (systolic and diastolic) at 6 and 12 weeks
mmHg.
Measured: 0, 6 and 12 weeks.
Change from Baseline Concentration of Triglycerides at 12 weeks
mg/dL.
Measured: 0 and 12 weeks.
Change from Baseline Concentration of Total Cholesterol at 12 weeks
mg/dL.
Measured: 0 and 12 weeks.
Change from Baseline Concentration of HDL Cholesterol at 12 weeks
mg/dL.
Measured: 0 and 12 weeks.
Change from Baseline Concentration of LDL Cholesterol at 12 weeks
mg/dL.
Measured: 0 and 12 weeks.
Change from Baseline Subjective level of quality of life at 12 weeks
Level of quality of life assessed by the test EuroQoL index, EQ-5D-5L. The score is the time trade-off (TTO). Scale from 11111 to 55555 being the higher the best health related quality of life.
Measured: 0 and 12 weeks.
Change from Baseline Physical activity at 12 weeks
Accelerometry, counts/min.
Measured: 0 and 12 weeks.
Change from Baseline Balance at 12 weeks
Level of balance assessed in a force platform. Newtons.
Measured: 0 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start15 Jan 2020
- Primary completion15 May 2020
- Study completion21 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Diabetes, University of Castilla-La Mancha, Castilla-La Mancha Health Service
- Responsible party
- Principal investigator, Amelia Guadalupe Grau, Technical University of Madrid
- Investigators
- Amelia Guadalupe Grau, PhD, Principal investigator, Technical University of MadridCarmen Ramírez Castillejo, PhD, Study chair, Technical University of MadridMarcela González Gross, Professor, Study director, Technical University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332302
- Sponsor's protocol ID
- SE1911600154
- Acronym
- DIAPOW
- Status last verified
- Oct 2020
- First submitted
- 30 Mar 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individualised report to all the participants after the completion of the study.
Publications
Guadalupe-Grau A, Carnicero JA, Gomez-Cabello A, Gutierrez Avila G, Humanes S, Alegre LM, Castro M, Rodriguez-Manas L, Garcia-Garcia FJ. Association of regional muscle strength with mortality and hospitalisation in older people. Age Ageing. 2015 Sep;44(5):790-5. doi: 10.1093/ageing/afv080. Epub 2015 Jul 11.
PubMed 26163682Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.
PubMed 24598478Garcia-Garcia FJ, Gutierrez Avila G, Alfaro-Acha A, Amor Andres MS, De Los Angeles De La Torre Lanza M, Escribano Aparicio MV, Humanes Aparicio S, Larrion Zugasti JL, Gomez-Serranillo Reus M, Rodriguez-Artalejo F, Rodriguez-Manas L; Toledo Study Group. The prevalence of frailty syndrome in an older population from Spain. The Toledo Study for Healthy Aging. J Nutr Health Aging. 2011 Dec;15(10):852-6. doi: 10.1007/s12603-011-0075-8.
PubMed 22159772Losa-Reyna J, Baltasar-Fernandez I, Alcazar J, Navarro-Cruz R, Garcia-Garcia FJ, Alegre LM, Alfaro-Acha A. Effect of a short multicomponent exercise intervention focused on muscle power in frail and pre frail elderly: A pilot trial. Exp Gerontol. 2019 Jan;115:114-121. doi: 10.1016/j.exger.2018.11.022. Epub 2018 Dec 4.
PubMed 30528641Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Rodriguez-Gomez I, Navarro-Cruz R, Losa-Reyna J, Garcia-Garcia FJ, Alegre LM. Force-velocity profiling in older adults: An adequate tool for the management of functional trajectories with aging. Exp Gerontol. 2018 Jul 15;108:1-6. doi: 10.1016/j.exger.2018.03.015. Epub 2018 Mar 20.
PubMed 29567100Alcazar J, Guadalupe-Grau A, Garcia-Garcia FJ, Ara I, Alegre LM. Skeletal Muscle Power Measurement in Older People: A Systematic Review of Testing Protocols and Adverse Events. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):914-924. doi: 10.1093/gerona/glx216.
PubMed 29309534Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Manas-Bote A, Guadalupe-Grau A, Garcia-Garcia FJ, Alegre LM. The Force-Velocity Relationship in Older People: Reliability and Validity of a Systematic Procedure. Int J Sports Med. 2017 Dec;38(14):1097-1104. doi: 10.1055/s-0043-119880. Epub 2017 Nov 10.
PubMed 29126339Guadalupe-Grau A, Aznar-Lain S, Manas A, Castellanos J, Alcazar J, Ara I, Mata E, Daimiel R, Garcia-Garcia FJ. Short- and Long-Term Effects of Concurrent Strength and HIIT Training in Octogenarians with COPD. J Aging Phys Act. 2017 Jan;25(1):105-115. doi: 10.1123/japa.2015-0307. Epub 2016 Aug 24.
PubMed 27402660
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Program on Physical Functionality and Frailty in Type 2 Diabetic Older Adults. Role of Circulating Concentration of PDEF and Differential Genes
- ClinicalTrials.gov ID
- NCT04332302
- Acronym / sponsor ID
- DIAPOW / SE1911600154
- Conditions
- Diabetes Mellitus, Type 2, Frailty
- Keywords
- Resistance Training, Quality of Life, Molecular Genetics, Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Collaborators
- Spanish Society of Diabetes, University of Castilla-La Mancha, Castilla-La Mancha Health Service
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 21 Dec 2021 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is a disease with a high impact in the population older than 65 years old. Some indications suggest that diabetes in the old age aggravate the negative effects of ageing, as the loss of muscle mass and strength, bringing the patients to a situation of vulnerability and elevated risk of disability and death known as "frailty syndrome". Recently, scientists have observed that if older population train with musculation machines emphasising the muscular power, it is possible to have an impact on a disminution of frailty and restoring the physical functionality. This project deeps in the physiological and molecular mechanisms that underlie to improvements in the frail diabetic patients.
Detailed description
It is hypothesised that:
- High intensity training (strength-power) prescribed properly in an individualised form and supervised could influence significantly on the phenotypic response in the DM type 2: decreasing the level of clinical severity, disability and frailty, improving quality of life and glycaemic control, functional capacity and body composition (especially the muscle mass) of the diabetic patients (type 2) older than 65 years old.
- Part of the training adaptations in diabetic patients (type 2) older than 65 years old could due to physiological conditions as the systemic level of biomarkers as PDEF in these patients.
- Part of the training adaptations in diabetic patients (type 2) could be influenced by the characterisation of associated genes to the different types of DM type 2 recently characterised.
The principal aims are:
- To evaluate the effectiveness of a novel intervention based on strength-power exercise in individuals older than 65 years old with DM type 2 and frailty in term of: level of clinical severity, disability, glycaemic control, quality of life, functional capacity, state of frailty and body composition.
- To establish whether PDEF serves as diagnostic and prediction biomarker to training response, providing an objective and accessible method that would stratify the response to the intervention helping with the patients screening.
- To determine the role of characterised genetic variants in the different subgroups of DM type 2 in the level of response to the training stimuli.
Study design Longitudinal intervention stratified study, controlled and single-blinded, with a group of intervention and control group.
Based on data from a previous study recently published by the collaborators of this project. The sample size was calculated to get statistically significant differences in the physical functionality using ANCOVA and performing a bilateral contrast with alpha=0.05 of the effect of the group (with any of the independent variables), and it is needed 30 subjects by group (total n=60) to get a statistical power of 80%, with a partial eta ≥ 0.101 (value that corresponds with the size of the moderate effect).
Exercise program The intervention period will have a duration of 12 weeks, in which the training group will perform 2 sessions per week (24 sessions in total), while the control group will not perform any type of intervention, following their normal lifes and the habitual medical cares. The experimental group will perform a program focused on the muscle power training, in which there will be included exercise of upper limbs (chest press) and lower limbs (leg press). The exercises will be performed in muscle-building machines available in the reference institutions of the collaborators. It is important to point out that the intensity in the exercises will be individualised for any patient through a test of determination of muscle power validated previously by the consortium of researchers and the subjects will perform the exercises at this intensity at which the subjects will develop their maximal muscle performance, with the performance of 3-4 bouts of 8 repetitions in each exercise. After the third week of intervention, it will be put the attention to the speed of execution. The duration of each session has been estimated in 20-30 minutes.
Finally, the subjects in the control group will serve to compare the interventions with exercise and the clinical conventional treatment, as well as to determine whether the training program is able to restore the functional capacity in a similar way in diabetic patients without frailty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power training group | Experimental | Other: Power resistance trainingParticipants will be enrolled in a resistance training program. |
| Control group | No intervention | –Participants will be doing their normal life. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Sign an informed consent.
- Older than 65 years old with Type 2 Diabetes Mellitus diagnosed in a minimum of 2 previous years.
- Being diagnosed frail, pre-frail or no frail.
Key exclusion criteria (7 listed)
- Barthel's index lower than 60 points.
- Incapacity to complete the SPPB fitness test.
- Score lower than 20 points in the Mini Mental State Examination.
- Cardiovascular event in the previous 6 months following the New York Heart Association (NYHA) classification.
- Patients clinically unstable by the investigator's judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power resistance trainingParticipants will take part in an intervention of 12 weeks duration in which they will train with musculation machines. | Other | Power training group |
Primary outcome
Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks
Time frame: 0 and 12 weeks.
Percentage
Change from Baseline Homeostasis Model Assessment - Beta cells (HOMA2-B) at 12 weeks
Time frame: 0 and 12 weeks.
Percentage
Change from Baseline Homeostasis Model Assessment - Insuline Resistance (HOMA2-IR) at 12 weeks
Time frame: 0 and 12 weeks.
Percentage
Change from Baseline Fried frailty score at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Level of frailty assessed by Fried Criteria. Intermediate or prefrail: 1 or 2 criteria present. Positive for frailty phenotype: ≥3 criteria present.
Change from Baseline Functional capacity at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Level of functional capacity assessed by the test SPPB. Scores 0-3: Very low physical function; Scores 4-6: Low physical function; Scores 7-9: Moderate physical function; Scores 10-12: High physical function
Change from Baseline Disability at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Level of disability assessed by the Barthel test. A participant scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.
Functional mobility at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Level of functional mobility assessed by the Lawton test. A scale from 0 to 8, expressing higher scores better levels of independence.
Change from Baseline Muscular power at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Watts.
Change from Baseline Levels of strength at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Load (kg).
Change from Baseline Bone Mineral Density at 12 weeks
Time frame: 0 and 12 weeks.
g/cm3
Change from Baseline Pigment Epitelium Derived Factor (PEDF) at 12 weeks
Time frame: 0 and 12 weeks.
Circulating level of PDEF assessed by Western Blot.
Genotyping of TCF7L2 (rs7903146)
Time frame: 0 week.
Assessed by Real-time PCR.
Genotyping of TM6SF2 (rs10401969)
Time frame: 0 week.
Assessed by Real-time PCR.
Genotyping of HLA (rs2854275)
Time frame: 0 week.
Assessed by Real-time PCR.
10 secondary outcomes
Change from Baseline Body Mass Index at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Change from Baseline Waist circumference at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Change from Baseline Blood pressure (systolic and diastolic) at 6 and 12 weeks
Time frame: 0, 6 and 12 weeks.
Change from Baseline Concentration of Triglycerides at 12 weeks
Time frame: 0 and 12 weeks.
Change from Baseline Concentration of Total Cholesterol at 12 weeks
Time frame: 0 and 12 weeks.
Change from Baseline Concentration of HDL Cholesterol at 12 weeks
Time frame: 0 and 12 weeks.
Change from Baseline Concentration of LDL Cholesterol at 12 weeks
Time frame: 0 and 12 weeks.
Change from Baseline Subjective level of quality of life at 12 weeks
Time frame: 0 and 12 weeks.
Change from Baseline Physical activity at 12 weeks
Time frame: 0 and 12 weeks.
Change from Baseline Balance at 12 weeks
Time frame: 0 and 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 26163682Guadalupe-Grau A, Carnicero JA, Gomez-Cabello A, Gutierrez Avila G, Humanes S, Alegre LM, Castro M, Rodriguez-Manas L, Garcia-Garcia FJ. Association of regional muscle strength with mortality and hospitalisation in older people. Age Ageing. 2015 Sep;44(5):790-5. doi: 10.1093/ageing/afv080. Epub 2015 Jul 11.
- Background: PubMed 24598478Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.
- Background: PubMed 22159772Garcia-Garcia FJ, Gutierrez Avila G, Alfaro-Acha A, Amor Andres MS, De Los Angeles De La Torre Lanza M, Escribano Aparicio MV, Humanes Aparicio S, Larrion Zugasti JL, Gomez-Serranillo Reus M, Rodriguez-Artalejo F, Rodriguez-Manas L; Toledo Study Group. The prevalence of frailty syndrome in an older population from Spain. The Toledo Study for Healthy Aging. J Nutr Health Aging. 2011 Dec;15(10):852-6. doi: 10.1007/s12603-011-0075-8.
- Background: PubMed 30528641Losa-Reyna J, Baltasar-Fernandez I, Alcazar J, Navarro-Cruz R, Garcia-Garcia FJ, Alegre LM, Alfaro-Acha A. Effect of a short multicomponent exercise intervention focused on muscle power in frail and pre frail elderly: A pilot trial. Exp Gerontol. 2019 Jan;115:114-121. doi: 10.1016/j.exger.2018.11.022. Epub 2018 Dec 4.
- Background: PubMed 29567100Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Rodriguez-Gomez I, Navarro-Cruz R, Losa-Reyna J, Garcia-Garcia FJ, Alegre LM. Force-velocity profiling in older adults: An adequate tool for the management of functional trajectories with aging. Exp Gerontol. 2018 Jul 15;108:1-6. doi: 10.1016/j.exger.2018.03.015. Epub 2018 Mar 20.
- Background: PubMed 29309534Alcazar J, Guadalupe-Grau A, Garcia-Garcia FJ, Ara I, Alegre LM. Skeletal Muscle Power Measurement in Older People: A Systematic Review of Testing Protocols and Adverse Events. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):914-924. doi: 10.1093/gerona/glx216.
- Background: PubMed 29126339Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Manas-Bote A, Guadalupe-Grau A, Garcia-Garcia FJ, Alegre LM. The Force-Velocity Relationship in Older People: Reliability and Validity of a Systematic Procedure. Int J Sports Med. 2017 Dec;38(14):1097-1104. doi: 10.1055/s-0043-119880. Epub 2017 Nov 10.
- Background: PubMed 27402660Guadalupe-Grau A, Aznar-Lain S, Manas A, Castellanos J, Alcazar J, Ara I, Mata E, Daimiel R, Garcia-Garcia FJ. Short- and Long-Term Effects of Concurrent Strength and HIIT Training in Octogenarians with COPD. J Aging Phys Act. 2017 Jan;25(1):105-115. doi: 10.1123/japa.2015-0307. Epub 2016 Aug 24.
- Individual participant dataSharing planned: Yes. Individualised report to all the participants after the completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amelia Guadalupe Grau, PhD principal investigator
Technical University of Madrid
Carmen Ramírez Castillejo, PhD study chair
Technical University of Madrid
Marcela González Gross, Professor study director
Technical University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power resistance training in people with Diabetes Mellitus, Type 2 and Frailty, run by Technical University of Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks (time frame: 0 and 12 weeks.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332302, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.